Long Term Follow-up of the TREOCAPA Study (TREOCAPA-LT)
This study is following up on an earlier trial called TREOCAPA. That trial looked at giving paracetamol (a common painkiller) to extremely premature babies (born before 29 weeks) in their first few days of life. The aim was to see if it helped close a small blood vessel near the heart called the ductus arteriosus, which often stays open in these babies and can cause problems. This new study, TREOCAPA-LT, will check how these children are developing at two years old using a questionnaire for their parents. We want to find out if the paracetamol treatment had any long-term effects on their brain development compared to those who didn't receive it.
At a glance
What is this study about?
When babies are developing inside their mother, they have a special blood vessel called the ductus arteriosus (DA). It helps blood flow away from their lungs, which aren't used for breathing yet. After birth, this vessel usually closes on its own within a day or two as the baby starts breathing. However, in babies born very early (before 29 weeks of pregnancy), this vessel often stays open. This is called a 'patent ductus arteriosus' (PDA).
A PDA can cause health issues in these vulnerable babies. In the past, doctors sometimes used specific strong medicines to help close it. But these medicines often came with side effects and didn't always improve the babies' overall health in the long run. Researchers then started looking into paracetamol, a common and gentler medicine, as a possible alternative to help close the DA.
The original TREOCAPA study was a large trial across Europe. It gave either paracetamol or a dummy medicine (placebo) to extremely premature babies in their first five days of life. The main goal of that study was to see if paracetamol could improve their survival without serious health problems while they were still in the hospital. This new study, TREOCAPA-LT, is a follow-up. It aims to understand if the paracetamol treatment given early in life had any impact on the children's brain development and learning abilities when they are about two years old. Parents of children who were part of the original TREOCAPA study may be asked to take part.
Key takeaways
- This study tracks children born extremely prematurely who were in an earlier trial.
- It's exploring the long-term effects of paracetamol given shortly after birth.
- The focus is on the child's brain and learning development at two years of age.
- Participation involves completing a simple questionnaire about your child.
- Your involvement helps improve future care for premature babies.
- You can choose not to participate at any time.
Who may be eligible?
To be part of this follow-up study, children must have already been enrolled in the original TREOCAPA trial at one of the participating hospitals.
They also need to be between about 23 and 27-and-a-half months old (this is their 'corrected age', meaning we adjust for how early they were born) during the time the study is collecting information.
There are some reasons why a child might not be able to take part. For example, if the hospital can't get in touch with the parents, or if a child is very unwell or nearing the end of their life. Also, if parents decide they no longer want to participate, or if there's a language barrier that prevents clear communication, they won't be included.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Was your child in the original TREOCAPA study?
- Is your child currently between 23 and 27.5 months old (corrected age)?
- Can the hospital easily contact you?
- Are you happy to complete a developmental questionnaire?
What does participation involve?
If you and your child are eligible and agree to take part, your involvement will be quite straightforward. We will ask you to complete a questionnaire about your child's development when they are around two years old (corrected age). This questionnaire will help us understand how your child is learning and growing. There are no hospital visits or medicines involved in this follow-up study. The total duration of your participation will be limited to the time it takes to complete this single questionnaire.
Potential risks and benefits
Locations (8)
- CHU d'AngersVerified postcodeAngers, France· Recruiting
- Hôpital Femme Mère EnfantVerified postcodeBron, France· Recruiting
- CHU de MontpellierVerified postcodeMontpellier, France· Recruiting
- CHU de NantesVerified postcodeNantes, France· Recruiting
- Cochin - APHPVerified postcodeParis, France· Recruiting
- Hopital Robert DebréVerified postcodeParis, France· Recruiting
- CHU de StrasbourgVerified postcodeStrasbourg, France· Recruiting
- CHU de ToursVerified postcodeTours, France· Recruiting
Common questions
What is 'corrected age'?
Corrected age is your child's age adjusted for how premature they were. For example, if a baby was born 2 months early, their corrected age at 4 months old would be 2 months.
Will my child get any medicine in this study?
No, this is a follow-up study. Your child received treatment (paracetamol or placebo) in the initial TREOCAPA study if they were part of it, but there are no medicines given in this follow-up.
What kind of questions will be on the questionnaire?
The questionnaire will ask about your child's development, like how they are learning to communicate, move, and solve problems, to understand their brain development.
Do I have to take part if my child was in the original study?
No, taking part is completely voluntary. Your child's medical care will not be affected whether you choose to participate or not.
How will my child's information be kept private?
All information collected will be kept confidential and personal details will be protected to ensure your child's privacy. Data will be anonymised where possible.
How to find out more
Gilles Cambonie, MD/PHD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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